COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04485130

Sulggi A. Lee, MD, PhD

Not reported

2020-07-24

Terminated

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: - willing and able to provide written informed consent, and - age >= 18 years, and - sars-cov-2 positive pcr (nucleic acid) test within the preceding 7 days, and - not currently hospitalized, and - willing to abstain from any alcohol during the two week period in which disulfiram will be administered and during the two week period immediately after disulfiram administration. - both male and female subjects are eligible. females of childbearing potential must have a negative pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.

- pregnant, breastfeeding, or unwilling to practice birth control during participation in the study - active malignancy requiring systemic chemotherapy or surgery in the preceding 3 months or for whom such therapies are expected in the subsequent 6 months - decompensated liver disease as defined by the presence of ascites, encephalopathy, esophageal or gastric varices, or persistent jaundice - serious illness requiring systemic treatment and/or hospitalization in the 3 months prior to study enrollment - concurrent treatment with immunomodulatory drugs, and/or exposure to any immunomodulatory drug in the 4 weeks prior to study enrollment (e.g. corticosteroid therapy equal to or exceeding a dose of 15 mg/day of prednisone for more than 10 days, il-2, interferon-alpha, methotrexate, cancer chemotherapy). note: use of inhaled or nasal steroid is not exclusionary. - serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent. - current alcohol use disorder or hazardous alcohol use (>7 drinks per week for women or > 14 drinks per week for men) as determined by clinical evaluation. - current use of any drug formulation that contains alcohol or that might contain alcohol - current use of warfarin. - clinically active hepatitis determined by the study physician; alt or ast > 3 x the upper limit of normal or total bilirubin outside the normal range. - allergy to rubber or thiuram derivatives

2

University of California, San Francisco

18

100

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

11

Immunologic impact of 5 days of disulfiram, as measured by the fold-change in plasma levels of pro-inflammatory cytokines (e.g, interleukin 6, interleukin 1-beta, etc.).

None

Phase 2

[{"arm_notes": " ", "treatment_id": 413, "treatment_name": "Disulfiram", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]